Designed to help advance patient outcomes and ease of use

Transcription

1 Introducing ULTRAPRO ADVANCED Macroporous Partially Absorbable Mesh for inguinal and ventral hernia repair Designed to help advance patient outcomes and ease of use t n rese rep otes n y k. r stic ights Colo mer ins o cust

2 ULTRAPRO ADVANCED Macroporous Partially Absorbable Mesh Inspired by your needs... designed with advanced features to benefit you and your patients Advanced features of ULTRAPRO ADVANCED Mesh Physiologically designed for comfortable healing Flexible in a way that approximates the natural movement of the abdominal wall, with 2:1 stretch 1-3 * Unique knitted mesh construction promotes good tissue ingrowth/tissue integration 4 Balanced strength for strong and lasting repair High suture pullout strength 3 High tensile strength 3 Withstands ~2x maximum intraabdominal pressure in healthy adults 3,5,6 No bulge visible in a preclinical study at 28 days and 91 days 4 *The abdominal wall stretches 2:1 at the linea alba (longitudinal to transversal). Compared with ULTRAPRO Macroporous Partially Absorbable Mesh, which has 4:1 stretch. Evidence shown in an animal model. 34% stiffer in transverse direction and 144% stiffer in longitudinal direction. Ethicon s honeycomb pore design accommodates multiple fixation devices 7 2

3 Designed for exceptional intraoperative handling Increased initial stiffness for easier handling 3 Springs open for easier deployment in laparoscopic repairs Packaged flat, without folds, for easier positioning Blue stripes facilitate orienting and positioning the mesh 8 Trimmable based on surgeon s discretion, while leaving sufficient overlap to help prevent recurrence 8 ULTRAPRO ADVANCED Mesh is designed to achieve the appropriate balance between flexibility and strength to help optimize patient outcomes and ease of use. 3 3

4 ULTRAPRO ADVANCED Macroporous Partially Absorbable Mesh Designed for exceptional intraoperative handling Blue orientation stripes facilitate orientation and placement and provide clear visualization of the underlying anatomy8 Springs open when passed through a trocar in laparoscopic repairs for easier handling and placement Surgeons rated ULTRAPRO ADVANCED Mesh highest in overall handling in open and laparoscopic repairs versus other meshes studied.9* * After performing an open and laparoscopic handling evaluation (n=10). Study compared ULTRAPRO ADVANCED Mesh, ULTRAPRO Macroporous Partially Absorbable Mesh, and Bard Soft Mesh. Compared with ULTRAPRO Mesh, which has 4:1 stretch. The abdominal wall stretches 2:1 at the linea alba As received mesh (mesh with absorbable component) Naked mesh (mesh after absorption) Evidence shown in an animal model. 4

5 Balanced strength for strong and lasting repair ULTRAPRO ADVANCED Mesh versus ULTRAPRO Mesh ULTRAPRO ADVANCED Mesh has 2:1 stretch to approximate the natural movement of the abdominal wall and withstands 2x maximum intraabdominal pressure in healthy adults. 1-3,5,6 Tensile strength Ratio of transverse to longitudinal is more evenly balanced (ie, 2:1 versus 5:1) 3 Suture pullout strength Transverse: 24% stronger 3 Longitudinal: 9% stronger 3 Density Increased density of 14% 3 ULTRAPRO ADVANCED Mesh is designed to reduce the potential for mesh bulging No bulge visible in a preclinical study at 28 days and 91 days 4 2x 1x 5

6 ULTRAPRO ADVANCED Macroporous Partially Absorbable Mesh Good tissue ingrowth with low foreign body mass Demonstrated results from a study of ULTRAPRO ADVANCED Mesh* at 28 days and 91 days 4 Good tissue ingrowth/tissue integration No evidence of mesh migration/compression, based on absence of wrinkling and folding at necropsy ULTRAPRO ADVANCED Mesh has low foreign body mass for a potentially more comfortable repair ULTRAPRO ADVANCED Mesh is designed to leave behind low foreign body mass after partial absorption 3 Macroporous design promotes host tissue penetration and fibrin fixation of the mesh to the tissue, helping to eliminate dead space and reduce the risk of seroma formation 10 Macroporous thin-filament design helps prevent bridging fibrosis 2 Low surface area may help reduce bacterial colonization Microporous meshes and multifilament meshes may pose a higher risk of infection 11 ULTRAPRO ADVANCED Mesh has a macroporous, thin-filament design that is partially absorbable, for low foreign body mass and comfortable healing. 2,12 * Approximately equal parts absorbable MONOCRYL (poliglecaprone-25) monofilament fiber to stiffen the mesh structure and nonabsorbable PROLENE (polypropylene) monofilament fiber for permanent support. Evidence shown in an animal model. 6

7 Built on the proven technology of ULTRAPRO Macroporous Partially Absorbable Mesh 13,14 In a study of 5 meshes, which included ULTRAPRO Mesh ULTRAPRO Mesh showed the highest biocompatibility at the implant site versus competitor meshes tested 15 Foreign body response at 4 weeks and 12 weeks Histology score weeks 12 weeks Parietex DualMesh Trelex ProLite ULTRAPRO Medium-density polyester mesh with pore size of 1.8 x 1.5 (Parietex ) induced the most pronounced foreign body reaction and most severe fibrosis Low-density polypropylene with poliglecaprone-25 mesh with pore size of 2 to 4 mm (ULTRAPRO Mesh) induced the least foreign body reaction and low fibrosis Parietex (polyester), DualMesh (eptfe), Trelex (polypropylene), ProLite (polypropylene), and ULTRAPRO Mesh (polypropylene with poliglecaprone). Foreign body response based on quantity of infiltrating foreign body giant cells. Low-density macroporous ULTRAPRO Mesh showed the highest biocompatibility at the implant site versus competitor meshes tested, based on foreign body response and fibrosis parameters Histology score: 0=none, 1=minimal/mild, 2=moderate, 3=severe The third-party trademarks mentioned herein are trademarks of their respective owners. 7

8 ULTRAPRO Macroporous Partially Absorbable Mesh Physiologically designed to get patients back to their prehernia lives Real-world, ongoing results since 2007 The Ethicon-sponsored International Hernia Mesh Registry (IHMR) is the largest international data registry with a vision to advance hernia repair. The IHMR provides prospective, longitudinal, patient-reported data on ventral, incisional, and inguinal hernia repairs for more than 4000 patients and reflects patient outcomes as seen in clinical practice. 16 The IHMR includes Ethicon products and non-ethicon products IHMR data are independently collected and managed by a third party Proven to reduce patients pain and improve movement limitation In 2 studies from the IHMR 13,14 * Patients receiving hernia repair with ULTRAPRO Mesh reported a statistically significant improvement in pain and movement limitation scores at 12 months postsurgery versus presurgery (P<0.001) 13,14 * *Data from a prospective, longitudinal study of 151 patients receiving open hernia repair with ULTRAPRO Partially Absorbable Lightweight Mesh from the International Hernia Mesh Registry (IHMR). Hernia types ; 53.0% incisional /ventral, 39.7% inguinal, 4.0% epigastric, 2.6% umbilical and 0.7% femoral. Common techniques utilized; 34.4% Lichtenstein, 29.8% Retro-rectus and 23.8% Preperitoneal. Fixation methods; 90.1% sutures, 6.0% sutures + glue,2.0% glue, 1.3% tackers+ sutures and 0.7% no fixation Data from a prospective, longitudinal study of 2792 patients receiving hernia repair with ULTRAPRO Hernia System from the IHMR. Mostly large size direct or combined groin hernias % were primary cases and 8.24% were recurrent cases. Data from a prospective, longitudinal study of 71 patients receiving open hernia repair with ULTRAPRO Plug from the IHMR. Two additional patient-reported recurrences could not be medically confirmed by a clinician. Hernia types: 90.2% inguinal; 8.7% umbilical; 1.1% femoral, 94.6% were primary repairs. Fixation methods: 97.8% sutures; 1.1 % sutures and glue; 1.1% none 8

9 Significant reduction in pain score at 1 year postsurgery versus presurgery 13 * CCS score P<0.001 Presurgery 12 months Change from baseline The IHMR uses the Carolinas Comfort Scale (CCS), a validated, hernia-specific quality-of-life tool for assessing early and long-term symptoms following hernia repair 17 The CCS uses a 6-point scale from 0 (no symptoms) to 5 (disabling symptoms) 17 The increased call for registries worldwide shows a growing focus on the value of utilizing patient outcome measurements in hernia repair *Data from a prospective, longitudinal study of 470 patients receiving laparoscopic hernia repair with ULTRAPRO flat mesh from the IHMR (96.6% inguinal, 3.4% other). 9

10 ULTRAPRO Macroporous Partially Absorbable Mesh Low rates of recurrence and complications Low rate of recurrence demonstrates strong and lasting repair 13,14 In 2 studies from the IHMR Patients demonstrated a rate of recurrence of <1% with ULTRAPRO Mesh 13,14* Recurrence rate of <1% at 1 year postsurgery 13,14 In the same 2 studies Low rates of complications, including infections, hematomas, and seromas 13,14 Most common adverse events Tollens et al. Berrevoet et al. Infection NA 4.6% Hematoma 1.3% 2.7% Seroma 3.6% 9.9% * Data from a prospective, longitudinal study of 470 patients receiving laparoscopic hernia repair with ULTRAPRO flat mesh from the IHMR (96.6% inguinal, 3.4% other). Data from a prospective, longitudinal study of 151 patients receiving open hernia repair with ULTRAPRO flat mesh from the IHMR (39.7% inguinal, 53.0% ventral/incisional, 7.3% other). 10

11 ULTRAPRO ADVANCED Macroporous Partially Absorbable Mesh is available in a range of sizes ULTRAPRO ADVANCED Mesh Product Specifications Ordering code Mesh size How supplied UPA x 12 cm Sterile, 3 per box UPA x 15 cm Sterile, 3 per box UPA x 15 cm Sterile, 3 per box UPA x 15 cm Sterile, 3 per box UPA x 30 cm Sterile, 1 per box UPA x 30 cm Sterile, 1 per box 11

12 ULTRAPRO ADVANCED Macroporous Partially Absorbable Mesh an advanced solution to meet your inguinal and ventral hernia repair needs Physiologically designed for comfortable healing 1-3 Balanced strength for strong and lasting repair 3,5,6 Designed for exceptional intraoperative handling 3,8,9 Patient outcomes based on the proven technology of ULTRAPRO Mesh 13,14 More than 40 sites worldwide ULTRAPRO ADVANCED Mesh is designed to achieve the appropriate balance between flexibility and strength to help optimize patient outcomes and ease of use. 3 The IHMR is the world s largest international hernia registry. 16 For more product information, go to For complete indications, contraindications, precautions, and adverse reactions, please reference full package insert. References: 1. Förstemann T, Trzewik J, Holste J, et al. Forces and deformations of the abdominal wall a mechanical and geometrical approach to the linea alba. J Biomech. 2011;44(4): Junge K, Klinge U, Prescher A, Giboni P, Niewiera M, Schumpelick V. Elasticity of the anterior abdominal wall and impact for reparation of incisional hernias using mesh implants. Hernia. 2001;5(3): Data on File. Ethicon, Inc. Vailhe E. Report for 510k testing for ETHICON ULTRAPRO ADVANCED, Version 1 (AST , technical report). 4. Data on File. Ethicon, Inc. Shnoda P. Final Report, PSE Accession No , Project No and 91-day definitive study of ULTRAPRO ADVANCED mesh to evaluate tissue integration and tissue reaction in a single stage hernia swine model. February 26, Data on File. Ethicon, Inc. Validation Report, Ultrapro Preproduction. Project PE 02/527. June 25, Cobb WS, Burns JM, Kercher KW, Matthews BD, Norton HJ, Heniford BT. Normal intraabdominal pressure in healthy adults. J Surg Res. 2005;129(2): Data on File. Ethicon, Inc. Chantereau P. Fixation Compatibility Test Reports. Project SAMS1. Project number March 25, ULTRAPRO ADVANCED Macroporous Partially Absorbable Mesh. Instructions for Use. Ethicon, Inc. 9. Data on File. Ethicon, Inc. Deichmann T. Surgeon feedback regarding handling and design characteristics of flat mesh prototypes. Program SAMS Phase 1. September Amid PK. Classification of biomaterials and their related complications in abdominal wall surgery. Hernia. 1997;1(1): Klinge U, Junge K, Spellerberg B, Piroth C, Klosterhalfen B, Schumpelick V. Do multifilament alloplastic meshes increase the infection rate? Analysis of the polymeric surface, the bacteria adherence, and the in vivo consequences in a rat model. J Biomed Mater Res. 2002;63(6): Holste JL. Are meshes with lightweight construction strong enough? Int Surg. 2005;90(3 suppl):s10-s Tollens T, Bringman S, Romanowski C, Jones P, McRoy L. Laparoscopic macroporous partially absorbable flat mesh 12 month outcomes from the IHMR. Poster presented at: 15th Annual Hernia Repair; March 13-16, 2013; Orlando, FL. 14. Berrevoet F, Tollens T, Romanowski C, Jones P, McRoy L. Open macroporous partially absorbable flat mesh 12 month outcomes. Poster presented at: 15th Annual Hernia Repair; March 13-16, 2013; Orlando, FL. 15. Orenstein SB, Saberski ER, Kreutzer DL, Novitsky YW. Comparative analysis of histopathologic effects of synthetic meshes based on material, weight, and pore size in mice. J Surg Res. 2012;176(2): International Hernia Mesh Registry (IHMR). NIH Clinical Trials Registry Web site. Available at: Accessed July 6, Colavita PD, Tsirline VB, Belyansky I, et al. Prospective, long-term comparison of quality of life in laparoscopic versus open ventral hernia repair. Ann Surg. 2012;256(5): Muysoms F, Campanelli G, Champault GG, et al. EuraHS: the development of an international online platform for registration and outcome measurement of ventral abdominal hernia wall repair. Hernia. 2012;16(3): Americas Hernia Society Quality Collaborative Web site. Available at: Accessed July 3, Ethicon US, LLC. All rights reserved